BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS DELIVERY SET

    MDR report key: 22873518 · Received August 22, 2025

    Report

    Report Number
    3005579300-2025-00013
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    June 11, 2024
    Report Date
    August 22, 2025
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    IWJ
    UDI-DI
    00850014612023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVED NO DEATH OR SERIOUS INJURY TO THE PATIENT AND THE PATIENT RECEIVED THEIR DOSE. THE DEVICE WAS RETURNED TO SIRTEX AND THE BROKEN/CRACKED PIECE WAS OBSERVED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ABNORMALITIES WERE OBSERVED DURING THE MANUFACTURE OF THE BATCH. A RETROSPECTIVE MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE POTENTIAL FOR SERIOUS INJURY IF UNDER DOSING OCCUR DUE TO PRESSURE/LEAKAGE.

    Description of Event or Problem · 0

    LUER-LOCK CONNECTION ON D LINE CRACKED AND BROKE OFF. AS THE DOCTOR WAS FINISHING ADMINISTRATION OF SIR-SPHERES, THE OUTER PORTION OF THE LUER-LOCK OF THE D LINE CONNECTION GOING INTO THE D-VIAL, CRACKED AND A PIECE FLEW ACROSS THE INSIDE OF THE SIROS BOX. AT THIS POINT, 30 ML OF D5 HAD ALREADY BEEN ADMINISTERED THROUGH THE D LINE, AND 30 ML OF 50/50 THROUGH THE B LINE. THE DOCTOR WAS STILL ABLE TO ADMINISTER AN ADDITIONAL 10-15 ML OF 50/50 THROUGH THE B LINE AND CONTRAST FLOWED THROUGH THE PROGREAT MICROCATHETER WITHOUT A PROBLEM. VISUAL INSPECTION OF D/C LINE WAS DONE AND NO CLUMPING OF PARTICLES WERE SEEN. THE DOCTOR DID NOT FEEL IT WAS SAFE TO CONTINUE ADMINISTRATION THROUGH THE D LINE WITH FEAR OF BUILDING UP ADDITIONAL PRESSURE WITHIN THE SYSTEM. THE CASE WAS COMPLETED AT THIS TIME. PRELIMINARY SURVEY SHOWED LESS THAN 5% RESIDUAL LEFT OF THE DOSE AND NO DETECTION OF RADIATION LEAKAGE WITHIN THE SIROS DOME. THOUGHTS ARE EITHER A DEFECTIVE/THIN PLASTIC ON THE LUER-LOCK AREA OR WHEN THE D LINE CONNECTIONS WERE ATTACHED, THAT THIS WAS POSSIBLY DONE TOO TIGHT. SYSTEM WAS LABELED TO SAVE FOR RETURN TO SIRTEX IF THEY WOULD LIKE TO ASSESS THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2638220 SIROS DELIVERY SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL PTY LIMITED SIR-10300 1109079 00850014612023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown